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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013570
Receipt No. R000015853
Scientific Title Study of comfort and effectiveness of the new catheter fixing method
Date of disclosure of the study information 2014/03/31
Last modified on 2016/02/17

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Basic information
Public title Study of comfort and effectiveness of the new catheter fixing method
Acronym Effect of medical glue on catheter fixation
Scientific Title Study of comfort and effectiveness of the new catheter fixing method
Scientific Title:Acronym Effect of medical glue on catheter fixation
Region
Japan

Condition
Condition surgical patients
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether fixity of the catheter can be improved by the combination of dressing tape and medical adhesive.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in the catheter length of insertion
Key secondary outcomes patient satisfaction, leakage of injectate, abnormalities of the skin

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 combination of dressing tape and medical glue for fixation of catheter
Interventions/Control_2 fixation with only dressing tape with suturing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Of the surgical patients, who undergo catheterization of peripheral nerve block or epidural
Key exclusion criteria Abnormalities in hemostasis and coagulation, contraindication of epidural anesthesia or peripheral nerve block
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soushi Iwasaki
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL 011-688-9663
Email iwasakis@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Murouchi
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL 011-688-9663
Homepage URL
Email g-fields@fc4.so-net.ne.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 札幌医科大学附属病院(北海道)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 28 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 31 Day
Last modified on
2016 Year 02 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015853

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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